The Diabetes in Early Pregnancy Project has the following objectives: 1) To examine the relationship between maternal diabetic control during organogenesis and malformations in the offspring. To identify, if possible, a specific teratogenic factor or factors in the diabetic metabolic state; and 2) To compare early fetal loss rates in women with diabetes and control subjects. The first objective has now been realized. The report on malformation rates in diabetic and control subjects has recently been published in The New England Journal of Medicine. In brief, we found that diabetic women who came into care before the period of organogenesis achieved better results than those who came in later; but their results were still poorer than our non-diabetic control subjects. Differences in maternal glucose levels during organogenesis did not explain the malformations in the offspring of the women who were followed throughout pregnancy. This leads us to suggest that other factors in addition to glucose may be teratogenic in diabetes. Our second objective, determining pregnancy loss rates in diabetic versus control pregnancies, is now being addressed. The data to answer this question have been generated and a report of our results is currently being prepared. Our results have been presented at several scientific meetings including the Society for Gynecologic Investigation, the American Diabetes Association and the Society for Epidemiologic Research.